Inspections, Compliance, Enforcement, and Criminal Investigations
2035, Inc. 3/3/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142
March 3, 2011
RETURN RECEIPT REQUESTED
Refer to MIN 11-14
Robert L. Lytle, DDS, PhD
President, 2035, Inc.
Managing Limited Partner, QLaser Healing Light LP
520 Kansas City Street, Suite 100
Rapid City, South Dakota 57701
Dear Dr. Lytle:
During an inspection of your firm located in Rapid City, South Dakota, on May 25 - 27, 2010, an investigator from the United States Food and Drug Administration (FDA) learned that your firms 2035, Inc. and QLaser Healing Light LP are marketing the Q10 Laser and 808 Enhancer Probe in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed internet websites (www.drlytle.com, www.qlaserhealinglight.com, http://qlaserspma.com and www.qlaserinformation.com), instructions and product warranty, and promotional brochures for the Q10 Laser, 808 Enhancer Probe, Q1000 Laser, and 660 Enhancer Probe. These products are devices within the meaning of section 201(h) of the Act, 21 U.S.C. § 321(h), because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
Q10 Laser and 808 Enhancer Probe
A review of our records reveals that you did not obtain marketing approval or clearance before you began offering the Q10 Laser and the 808 Enhancer Probe for sale, which is a violation of the law. Specifically, the Q10 Laser and the 808 Enhancer Probe are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency, Title 21, Code of Federal Regulations, section 807.81(b), (21 CFR 807.81(b)). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Please notify this office in writing within 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Q1000 Laser and 660 Enhancer Probe
A review of our records indicates that we cleared a premarket notification (510(k)) for the Q1000 Laser and 660 Enhancer Probe (QLaser System), K080513, with an intended use “for providing temporary relief of pain associated with osteoarthritis of the hand, which has been diagnosed by a physician or other licensed medical professional.”
However, the information on your websites currently located at www.drlytle.com, www.qlaserhealinglight.com, http://qlaserspma.com and www.qlaserinformation.com and in promotional brochures states multiple claims about the QLaser System, which include, but are not limited to, the following:
1. From the QLaser Use Instructions & Product Warranty (page 4):
• “Use Mode 1 to re-energize muscle, ligament and tendon cells for healing wounds and injuries or for reducing pain and inflammation; Mode 1 also benefits tendonitis, arthritis, burns, sprains, cuts, bruises, muscle pulls, sore throat, and any pain or inflammation.”
• “Use Mode 2 to re-energize brain and heart cells and to normalize brain neuropeptides and heart cell energy.”
• “Use Mode 3 as a multi-organ cell re-energizer that cycles through 29 different frequencies proven effective and beneficial for healing, and to benefit inflammation or disorders of all internal, and for the treatment of any unknown condition.”
2. From the QLaser Low Level Laser Therapy promotional brochure (pages 4 and 7):
• From Page 4 -“The Q1000 is used for acute or chronic pain and inflammatory conditions.”
• From Page 7 - “Q1000 Helps Balance the Autonomic Nervous System.”
• Verbal statements from the video entitled “Healing Light Low Level Therapy and the QLaser System”
“There’s just unlimited things that the laser will do from migraines to asthma to sciatic nerves.” – Narrator (beginning at 00:00:25)
(In addition, this video is available at a YouTube Channel registered to QLaserHealingLight, http://www.youtube.com/user/qlaserhealinglight.)
• From Dr. Lytle’s article entitled “Shedding Light on Macular Degeneration”
“To sum it up, if electrical micro current or biocurent [sic] is effective, low level lasers should be equally or more effective for Age Related Macular Degeneration, especially if the laser is used early-on as a preventive procedure.”
Promotion of these devices for claims other than those cleared in the 510(k) premarket notification, including the above claims, whether explicitly or implicitly, represents a major change or modification in the intended use of your device that requires a new premarket notification, 21 CFR 807.81(a)(3)(ii). Because of these claims, the Q1000 Laser and 660 Enhancer Probe are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because you did not submit to FDA a notification respecting the changes to the intended use of the device, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
FDA requests that 2035, Inc. and QLaser Healing Light LP immediately cease marketing the Q1000 Laser and 660 Enhancer Probe for unapproved uses such as those above. Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for the Q1000 Laser and 660 Enhancer Probe, the same as or similar to those described above, and explaining your plan for discontinuing use of such materials.
The FDA received six letters from you following the aforementioned inspection of May 25 - 27, 2010:
• June 15, 2010 (Re: Rescission of Activities and Practices Involving Low Level Laser Devices)
• June 15, 2010 (Re: Respondent’s Request for Copy of Complaint and a Pre-Administrative Hearing…)
• June 20, 2010 (Re: Notice of Non-Compliance with the Privacy Act…)
• June 25, 2010 (Re: Request for Rules of Interpretation or Construction for FDA Statutes and/or Regulations)
• June 25, 2010 (Re: Request for Copies of Oaths of Office for FDA Officers and Employees)
• June 25, 2010 (Re: Request for Permission to Manufacture and Market Products to Private Members only in the Private Domain)
The above letters fail to adequately address the violations cited in this Warning Letter. Your June 15, 2010, letter (Re: Rescission of Activities…) states that “…all manufacturing and sale of our products to the public is hereby terminated.” However, this does not appear to be true because as of January 12, 2011, your websites www.drlytle.com, www.qlaserhealinglight.com, http://qlaserspma.com and www.qlaserinformation.com were still operating and contain claims other than those cleared in the 510(k) premarket notification.
You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please direct your response to Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612)758-7133. We remind you that only written communications are considered official.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Gerald J. Berg